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Completed

NCT Number: NCT00554528

Arthroplasty Versus Fusion in Anterior Cervical Surgery: Prospective Study of the Impact on the Adjacent Level

The aim of the study is to evaluate the impact of the cervical disk surgery on the deterioration of the adjacent levels. The investigators compare the radiological deterioration of adjacent levels, at 3 years, in both situation of fusion and arthroplasty. 220 patients are enrolled and randomized to receive fusion or prosthesis. Radiological and clinical follow-up is organized for a period of 3 years.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Neurosurgery, CHU de Nice

Nice, 06000, France

About this study

Anterior surgery of the cervical spine is one of the most practiced procedures in spine surgery. Its immediate accuracy and safety is proved since a long time in case of degenerative disk disease or disk herniation. But the segmental arthrodesis leads to an overload of the adjacent disk. A lot of studies have shown that the increasing mobility and pressure of the adjacent segments can be responsible of new degeneration and clinical symptoms. Recently, cervical disk prosthesis have been developed to maintain the mobility at the level of the surgery. This technique is supposed to decrease the risk of adjacent disk disease but, at this time, the analysis of the results is difficult, due to the lack of randomized studies with long term follow up.

The aim of our prospective randomized study is to evaluate the aftermath of the arthroplasty compared to the fusion on the adjacent disk degeneration.

The main objective is to show a radiological difference at 3 years in term of adjacent disk degeneration.

The secondary objectives are:

  • evaluate the rate of new clinical symptoms during three years
  • show differences during the postoperative period, especially concerning the length of the hospital stay, the use of pain killers and return to work.
  • verify the maintaining of mobility pf the prosthesis during three years.

This is a controlled study with two group of equal size: one group is treated by discectomy and arthrodesis and the other by discectomy and prosthesis/ The criteria for the inclusion of the patients are: clinical radiculopathy and/or myelopathy due to a cervical disk disease (disk herniation or osteophytosis), lack of effect of the medical treatment, CT scan or MRI showing a compression of roots and/or spinal cord.

The main exclusion criteria are: plurisegmental disk disease, injuries happened during professional activities, previous cervical surgery.

During the study, we perform a clinical (standardized scales: Neck Disability Index, Short Form 36, and neurological exam) and a radiological (height of the adjacent disks, ostheophytis,…) follow-up.

The analysis of the current literature and statistical process leads to a total amount of 220 patients enrolled in the study. This is a multicentric study organized for a total duration of five years (two years for inclusions and three years of follow-up).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • clinical radiculopathy
  • myelopathy due to a cervical disk disease
  • lack of effect of the medical treatment
  • CT scan or MRI showing a compression of roots and/or spinal cord

Exclusion criteria

  • plurisegmenta disk disease
  • injuries happened during professional activities
  • previous cervical surgery

Treatment and study plan

cervical disc prosthesis with a mobile insert named Mobi-C

Device

Stage 1: partial discectomy

stage 2: location of the medial axis

stage 3: centering pin

stage 4: installation of the caspar spacer

stage 5: total discectomy

stage 6: parallel distraction

stage 7: depth measurement

stage 8: trial implant

stage 9: assembly

stage 10: implant insertion

stage 11: anchorage optimization

arthrodesis - cervical disk surgery

Procedure

discectomy and arthrodesis

Primary outcomes

  1. show significant difference of degeneration of disc above and below the operated stage between the two groups

    Time frame: 3 years after surgery

Secondary outcomes

  1. show difference of neurological pain between the two groups

    Time frame: during the 3 years of follow-up

  2. show difference of duration of hospitalization and consumption of medication

    Time frame: during the first month after surgery

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: PROCERV

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Nov 7, 2007
Registry last updated
Sep 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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